Evaluation of Mineral Absorption in Infants Fed Infant Formula

This study has been completed.

Sponsor:

Information provided by:

Mead Johnson Nutrition

ClinicalTrials.gov Identifier:

NCT01177917

First received: August 6, 2010

Last updated: NA

Last verified: August 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	August 6, 2010
Last Updated Date	August 6, 2010
Start Date ^ICMJE	August 2006
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 6, 2010)	To evaluate the amount of minerals in the urine
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: August 6, 2010)	Compare the amount of vitamins and minerals in the blood
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of Mineral Absorption in Infants Fed Infant Formula
Official Title ^ICMJE	Not Provided
Brief Summary	This clinical trial will help determine if prebiotics can increase mineral absorption in babies
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Mineral Absorption in the Urine
Intervention ^ICMJE	Other: Infant Formula
Study Arm (s)	Experimental: Cow milk-based infant formula with prebiotic blend Intervention: Other: Infant Formula Placebo Comparator: Marketed Cow milk-based infant formula Intervention: Other: Infant Formula
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	October 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Singleton Term infant Birth weight of 2500 g or more 56-70 days of age Signed informed consent Consuming a cow's milk-based infant formula for at least 24 hours. Exclusion Criteria: History of underlying disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the mineral absorption of the participant Use of multiple vitamin and mineral supplements prior to enrollment. Evidence of formula intolerance or poor intake at time of randomization
Gender	Both
Ages	56 Days to 70 Days
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01177917
Other Study ID Numbers ^ICMJE	3371-4
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Mead Johnson Nutrition
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mead Johnson Nutrition
Verification Date	August 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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